BeOne Medicines (ONC/688235.SS): Quick China approval for sonro; eyes on market feedback for differentiation; Buy Sonro approved in China for late-line CLL/MCL: On Jan 5th, China NMPA approved sonrotoclax (BCL2 inhibitor) in R/R CLL/SLL and R/R MCL (post CD20/BTKi treatment), marking the first approval of sonrotoclax across markets (the FDA accepted NDA in R/R MCL in Nov. 2025 with priority review). The China approval took only eight months to complete the NDA review, which we view as quick compared to typi ...

6 January 2026 | 8:05AM HKT Equity Research BeOne Medicines (ONC/688235.SS): Quick China approval for sonro; eyes on market feedback for differentiation; Buy Sonro approved in China for late-line CLL/MCL: On Jan 5th, China NMPA approved sonrotoclax (BCL2 inhibitor) in R/R CLL/SLL and R/R MCL (post CD20/BTKi treatment), marking the first approval of sonrotoclax across markets (the FDA accepted NDA in R/R MCL in Nov. 2025 with priority review). The China approval took only eight months to complete the NDA rev ...

BeOne Medicines, a global drug company that originated as a research and development (R&D) firm in Beijing, promoted Wang Lai to the newly created role of co-president, marking a leadership expansion as the company advances its late-stage pipeline and globalisation efforts. The 48-year-old has served as the company's global head of R&D since April 2021. Effective January, Wang would take the helm of an expanded portfolio, retaining his R&D responsibilities while also overseeing business development and th ...

Core Insights - Jazz Pharmaceuticals (JAZZ) shares increased nearly 21% following the announcement of positive results from the HERIZON-GEA-01 study, which evaluated Ziihera (zanidatamab) as a first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) [1][8] Study Results - The HERIZON-GEA-01 study compared two regimens: Ziihera plus chemotherapy and Ziihera combined with BeOne Medicines' PD-1 inhibitor Tevimbra plus chemotherapy, against the standard of care treatment, trastuzumab plus chemotherapy [2] - Both regimens demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS), achieving one of the study's dual primary endpoints [3] - For overall survival (OS), the three-drug regimen showed significant improvements, while the two-drug regimen indicated a strong trend toward statistical significance [4] Future Plans - Jazz intends to present detailed data from the HERIZON-GEA-01 study at a medical meeting in the first quarter of 2026 [5] - The company plans to seek label expansion for Ziihera in the GEA indication in the first half of 2026 based on the study results [6] Stock Performance - Following the positive study results, Jazz shares reached a 52-week high, with the findings suggesting Ziihera's potential to become the new standard of care for first-line HER2+ GEA, an area with significant commercial potential [7] - Year-to-date, JAZZ stock has risen 38%, outperforming the industry growth of 15% [7] Development Pipeline - The HERIZON-GEA-01 study marks the first late-stage results for Ziihera, which is also being developed in late-stage studies for first-line biliary tract cancer (BTC) and metastatic breast cancer [10] - Additionally, Ziihera is under evaluation in two mid-stage studies for HER2-positive solid tumors and HER2+ neoadjuvant and adjuvant breast cancer [11] Licensing Agreement - Ziihera was acquired through a licensing agreement with Zymeworks, granting Jazz exclusive rights to develop and market the drug outside of Asia/Pacific [12]

Company Highlights - Jazz Pharmaceuticals PLC shares rose 18% to $166.56 after announcing positive top-line results from the Phase 3 HERIZON-GEA-01 trial for Ziihera in combination with chemotherapy for HER2-positive gastroesophageal adenocarcinoma [2] - PACS Group, Inc. shares jumped 49.5% to $15.82 ahead of its third-quarter results release on November 19 [5] - Sigma Lithium Corporation gained 30.5% to $7.91 following bullish FY26 demand guidance from Ganfgeng Lithium Group's chairman [5] - Zymeworks Inc. shares rose 29.5% to $24.00 due to significant improvements reported in the HERIZON-GEA-01 study [5] - Nuvalent Inc surged 16.5% to $112.44 after announcing positive pivotal data from the ALKOVE-1 clinical trial [5] - Vita Coco Company Inc shares jumped 9.1% to $47.84 after an upgrade from B of A Securities from Neutral to Buy, with a price target increase from $48 to $54 [5] Market Overview - U.S. stocks were lower, with the Dow Jones index falling more than 100 points on Monday [1]

Core Insights - Summit Therapeutics (SMMT) reported a third-quarter 2025 loss per share of 31 cents, significantly wider than the Zacks Consensus Estimate of a loss of 14 cents, and compared to a loss of 8 cents in the same period last year [1][2][9] - The company currently has no marketed products, resulting in no recorded revenues for the quarter [2] - Adjusted research and development expenses rose to $90.5 million, a 184% increase year over year, primarily due to higher clinical costs [3] - Adjusted general and administrative expenses increased by 82% year over year to $12.9 million, driven by costs associated with developing ivonescimab [3] - As of September 30, 2025, the company had cash and short-term investments totaling $238.6 million, down from $297.9 million as of June 30, 2025 [4] Pipeline Developments - Summit has one pipeline drug, ivonescimab, a bispecific antibody targeting PD-1 and VEGF, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [5] - The company plans to submit a regulatory filing to the FDA by year-end for ivonescimab plus chemotherapy for adults with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC [6] - Data from the HARMONi study indicated a favorable trend in overall survival, despite not meeting the primary endpoint [6] - Additional data from the HARMONi-6 study showed ivonescimab reduced the risk of disease progression or death by 40% compared to BeOne Medicines' Tevimbra [7] - Major protocol amendments were announced for the HARMONi-3 study, which will now include separate analyses for squamous and non-squamous NSCLC [8] - The company is expanding ivonescimab's development to include a phase III study for unresectable metastatic colorectal cancer (CRC), with enrollment expected to start before year-end [12][13] Market Reaction - Shares of Summit fell nearly 5% following the announcement of the amended HARMONi-3 protocol, reflecting investor concerns over the changes and the wider-than-expected loss reported [9][10] - Year to date, the stock has risen over 12%, outperforming the industry average increase of 9% [10]

Core Insights - Summit Therapeutics (SMMT) reported a second-quarter 2025 loss per share of $0.76, significantly wider than the Zacks Consensus Estimate of a loss of $0.10, and compared to a loss of $0.09 in the same period last year [1][7] - The company currently has no marketed products, resulting in no recorded revenues for the quarter [2] - Year-to-date, SMMT shares have increased by 58.3%, outperforming the industry average increase of 5.3% [2] Financial Performance - Adjusted research and development expenses reached $79.4 million, a 190.8% increase year-over-year, primarily due to higher costs for expanding clinical studies for ivonescimab [4] - Adjusted general and administrative expenses rose by 64.5% year-over-year to $10.2 million, driven by costs associated with developing infrastructure for ivonescimab [4] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $297.9 million, down from $361.3 million as of March 31, 2025 [5] Pipeline Developments - Summit's only pipeline drug, ivonescimab, is a first-in-class bispecific antibody targeting PD-1 and VEGF, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [8] - The phase III HARMONi study showed that ivonescimab plus chemotherapy reduced the risk of disease progression by 48% compared to chemotherapy alone, but did not achieve statistically significant overall survival benefits [9][10] - The company plans to file for approval of the ivonescimab-chemo combination for previously treated EGFR-mutated NSCLC, pending further discussions with the FDA regarding the need for statistically significant overall survival benefits [10] Recent Study Results - Positive results were reported from the Akeso-sponsored phase III HARMONi-6 study, where ivonescimab plus chemotherapy showed significant improvement in progression-free survival compared to BeiGene's PD-1 inhibitor [11] - The HARMONi-3 study is evaluating ivonescimab against Merck's Keytruda in first-line metastatic NSCLC patients [12] - The HARMONi-2 study previously demonstrated that ivonescimab outperformed Keytruda in patients with positive PD-L1 expression [13] Collaborations and Approvals - Akeso has secured approval for ivonescimab in a second indication for front-line PD-L1 positive advanced NSCLC based on HARMONi-2 results [14] - Summit has entered clinical trial collaborations with Pfizer and Revolution Medicines to evaluate ivonescimab in combination with their drugs across various solid tumor settings [15]

Summary of BeOne Medicines (ONC/688235.SS) Earnings Review Company Overview - BeOne Medicines is a global oncology company based in Switzerland, focusing on innovative cancer treatments, particularly in hematology and solid tumors, with key products including Brukinsa and Tevimbra [13][14]. Key Financial Highlights - **2Q Product Sales**: Achieved US$1.3 billion, a 41% year-over-year increase, surpassing expectations (GSe: US$1.23 billion) [1] - **Brukinsa Sales**: Contributed US$684 million, reflecting a 43% year-over-year growth and a 21% quarter-over-quarter increase [1] - **Tevimbra Sales**: Reported US$194 million, a 22% year-over-year increase, with strong performance in China [1] - **China Sales**: Reached US$83 million, a 31% year-over-year increase [1] Guidance and Profitability - **FY25 Guidance**: Raised from US$4.9 billion to a range of US$5.0 billion to US$5.3 billion [1] - **Net Income**: Increased to US$94 million in 2Q, compared to US$1 million in 1Q, driven by strong topline growth and a gross profit margin (GPM) of 87.4% [2] - **Operating Expenses**: SG&A expenses were US$538 million (+21% y/y), and R&D expenses were US$525 million (+15% y/y) [2] Market Position and Competitive Landscape - **Market Share**: Brukinsa continues to gain market share among BTK inhibitors, with a 38% share in the US [1][11] - **1L CLL Position**: Management expressed confidence in maintaining a strong position against competition from pirtobrutinib, citing the need for head-to-head trials for new entrants [7] Future Catalysts - **Upcoming Milestones**: Key trials and data readouts expected in the next 12 months include: - Brukinsa: Phase 3 MANGROVE trial readout in TN MCL in 2H25 - Sonrotoclax: First global registrational filing in R/R MCL in 2H25 - BTK CDAC: Phase 3 initiation in R/R CLL in 2H25 [8] Valuation and Price Target - **Earnings Estimates**: Adjusted FY2025-2027 earnings estimates to US$2.77, US$6.61, and US$8.04 respectively [9] - **Target Prices**: Updated 12-month target prices to US$378.20 for ONC and Rmb328.65 for A-share [9][14] Risks and Considerations - **Key Risks**: Include uncertainties in R&D and regulatory approvals, competition in the BTK/PD-1 space, and potential market access bottlenecks [13][14]. Conclusion - BeOne Medicines is positioned for growth with strong sales performance, raised guidance, and a robust pipeline. The company is well-placed to navigate competitive pressures and capitalize on upcoming clinical milestones [13][14].

Core Viewpoint - Summit Therapeutics' shares increased nearly 9% following reports of AstraZeneca's interest in a potential licensing deal worth up to $15 billion for its experimental drug ivonescimab [1][2]. Group 1: Licensing Deal Details - AstraZeneca is considering a deal that may include "several billion dollars" in upfront payments, with the remainder contingent on milestone payments related to ivonescimab's development [2]. - The ongoing discussions have not been confirmed by either AstraZeneca or Summit Therapeutics, and there is a possibility that the deal may not materialize or that Summit may choose a different partner [3]. Group 2: Drug Performance and Development - Ivonescimab has shown promising results in clinical trials, significantly reducing the risk of disease progression or death in patients with advanced non-small cell lung cancer (NSCLC) compared to Merck's Keytruda [4]. - The drug is being developed in collaboration with Akeso, which originally developed ivonescimab, and Summit acquired exclusive rights to market the drug in various regions, including the U.S. and Europe [5]. Group 3: Market Context and Competitive Landscape - The stock of Summit Therapeutics has increased by 38% year-to-date, outperforming the industry average growth of 4% [6]. - The interest from AstraZeneca reflects a broader trend in oncology towards developing bispecific antibodies targeting both PD-1 and VEGF proteins, an area where Summit has established itself as a pioneer [9]. - If the licensing deal is finalized, AstraZeneca would gain a competitive edge in the bispecific antibody market, potentially surpassing competitors like Merck and Pfizer [10].

Investment Rating - The report assigns a "Buy" rating to Summit Therapeutics Inc. (SMMT) with a 12-month price target of $41, indicating an upside potential of 90.2% from the current price of $21.56 [9]. Core Insights - The report highlights positive Phase 3 (HARMONi) data for ivonescimab combined with chemotherapy in second-line EGFR-mutant non-small cell lung cancer (NSCLC), suggesting that data from China can be translated to Western patients [2][3]. - Management anticipates full data from the Akeso Phase 3 HARMONi-6 study, which shows ivonescimab's benefits in first-line squamous NSCLC, to be presented at the ESMO meeting in October 2025 [2][5]. - Recent overall survival (OS) data from the HARMONi-2 study supports the translatability of ivonescimab's progression-free survival (PFS) benefits to OS, with management expecting statistically significant OS results in ongoing global studies [6][7]. - The company plans to explore partnership opportunities to accelerate the global development of ivonescimab and expand its indications beyond NSCLC [7]. Summary by Sections Phase 3 Trials - The global Phase 3 HARMONi trial involves approximately 420 patients and compares ivonescimab against placebo in combination with chemotherapy for second-line treatment of non-squamous EGFRm NSCLC [3][5]. - Initial topline data from the trial indicates a statistically significant PFS hazard ratio of 0.52, suggesting a strong efficacy profile [5]. Business Development - Management is focused on identifying partnership opportunities to facilitate rapid global development of ivonescimab, emphasizing the need for collaboration with larger players in the industry [7]. - The competitive landscape for PD-1/L1xVEGF therapies is seen as validating for the class, with SMMT aiming to maintain its leadership position [6][7]. Future Outlook - The report anticipates that the upcoming full data from the HARMONi-6 study will provide clarity on the efficacy of ivonescimab in combination with chemotherapy compared to existing standards of care [6]. - Management plans to provide updates on the timelines for the HARMONi-3 study in the second half of 2025, with strong enrollment noted to date [6].